MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158125110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); Rash (2033); Discomfort (2330); No Code Available (3191)
Date of Event	11/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the patient had his knee replaced sometime in 2017, the exact date is unknown.The patient came to er on (b)(6) 2019 because his knee was swollen, sore, and had a rash on his leg.The surgeon was on call so he was assigned the consult.He aspirated the knee and seen puss which at that point decided to do a i&d on this patient¿s knee replacement.The sz 5 x 10mm ps insert was explanted and exchanged with a new insert.The femoral, tibial, and patella components were left implanted.The lot # could not be read so the lot # could not be documented.No other information is available at this time.Doi: unknown; dor: (b)(6) 2019; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA STAB XLK INS 5 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9413222
• Report Number: 1818910-2019-120409
• Device Sequence Number: 11221369
• Product Code: JWH
• UDI-Device Identifier: 10603295064664
• UDI-Public: 10603295064664
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 158125110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 117